Oncology Venture advancing towards next milestone in its clinical development of 2X-121.

Company News

Hørsholm, Denmark (12 November 2019) – Oncology Venture A/S ("OV” or the Company) today announced an update on the progress of its ongoing U.S. Phase 2 clinical trial for its PARP inhibitor, 2X-121, for the treatment of ovarian cancer, sited at the Dana-Farber Cancer Institute (Boston, MA, U.S.A.).

The cancer drug 2X-121 (formerly E7449) is a small molecule, targeted inhibitor of Poly ADP-Ribose Polymerase (PARP), a key DNA damage repair enzyme active in cancer cells, which was originally developed by the pharmaceutical company Eisai.  The company has recently announced this drug as one of its top priority programs. 

2X-121 is currently being evaluated for the treatment of advanced ovarian cancer in a DRP®-guided Phase 2 clinical trial at the Dana-Farber Cancer Institute (Boston, MA U.S.A.).  Thus far, 8 patients are enrolled in the study, with ongoing enrollment towards a target of 30 patients.  The Company is opening a second trial site, at Guy’s Hospital (London, UK) to accelerate patient accrual to the trial.   Guy’s Hospital was the site of the prior Phase 1 study of 2X-121 under sponsorship by Eisai.  Through use of DRP® patient selection, OV aims to provide a superior clinical benefit, to ovarian cancer patients receiving 2X-121, as compared to other approved PARP inhibitors. The global PARP inhibitor market is projected to reach USD 9 billion by 2027 in ovarian cancer.

Steve R. Carchedi, CEO of Oncology Venture, commented "We are excited to announce the ongoing progress of our key Phase 2 clinical trial for 2X-121 at one of the world’s leading cancer and personalized medicine centers.   The approval and use of PARP inhibitors for the treatment of a variety of cancers is an exciting area that is rapidly expanding, and we are confident our Phase 2 study will prove the merits of our drug, together with its DRP® companion diagnostic, as we advance towards approval and commercialization of this priority asset in our pipeline.”

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About Oncology Venture A/S
Oncology Venture A/S is engaged in the clinical development towards commercialization of anti-cancer drugs in a "precision medicine” approach utilizing a proprietary Drug Response Predictor (DRP®) platform technology to significantly increase the probability of success in clinical trials and the improvement of patient outcomes. DRP^® is a best-in-class predictive biomarker (companion diagnostic) technology that has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, and is currently demonstrating promising prospective results in an ongoing phase 2 study of LiPlaCis® for metastatic breast cancer. DRP^® enables the selection and treatment of highly likely responder patients to a given cancer drug, thus substantially increasing the likelihood of clinical trial success and improved patient outcomes, as compared with traditional pharmaceutical development.   DRP® enables selection of a more well-defined patient group, leading to decreased risks and costs while the development process becomes more efficient, and patient outcomes become improved.

The current OV product portfolio includes seven cancer drugs:  2X-121 -- a PARP inhibitor in an ongoing Phase 2 for ovarian cancer; Dovitinib -- a post Phase 3 product, being prepared for a US NDA approval filing in renal cell carcinoma (RCC); IXEMPRA® (Ixabepilone) – an approved and marketed (U.S.) microtubule inhibitor being advanced for Phase 2 development (in EU) for treatment of breast cancer;  LiPlaCis^® -- a liposomal formulation of cisplatin in an ongoing Phase 2 trial for breast cancer 2X-111 – a targeted, liposomal formulation of doxorubicin staged for Phase 2 development for the treatment of brain metastases of breast cancer; Irofulven – a DNA damaging agent in an ongoing Phase 2 trial in prostate cancer; and APO010 - an immuno-oncology product staged for Phase 2 development for the treatment of multiple myeloma.  The Company’s current priority program focus is for advancement of 2X-121, IXEMPRA®, and Dovitinib.

Learn more at oncologyventure.com

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Forward-looking statements 
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of OV’s control and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning OV’s plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. OV undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Email: ca@skmg.se. Tel: +46 11 32 30 732

This information is information that Oncology Venture A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication on November 12, 2019.

Attachment

• OV Press Release_2X-121 Update_November